Coronary Revascularization after Transcatheter and Surgical Aortic Valve Replacement.

INTRODUCTION: Due to the selective criteria and short-term follow-up of previous transcatheter aortic valve implantation (TAVI) trials, the coronary revascularization incidence after TAVI has been difficult to determine. This study investigated the epidemiology of coronary revascularization after surgical aortic valve replacement (SAVR) and TAVI in patients with severe aortic valve stenosis (AS), with and without coronary artery disease (CAD), in a mid-term follow-up, single-center, real-world setting. METHODS: Between 2010 to 2020, 1486 patients with AS underwent SAVR or TAVI with balloon-expandable Edwards® transcatheter heart valves (THVs). Using hospital discharge records, we could estimate for each patient resident in Emilia Romagna the rate of ischemic events treated with percutaneous coronary intervention (PCI). A subgroup without CAD was also analyzed. RESULTS: The 5-year overall survival was 78.2%. Freedom from PCI after AVR and TAVI at 5 years was 96.9% and 96.9%, respectively, with previous PCI as a predictor (HR 4.86, 95% CI 2.57-9.21 p < 0.001). The freedom from PCI curves were not significantly different. CONCLUSIONS: Notwithstanding the aged population, the revascularization incidence was only 2.4%, requiring further evaluation even in younger patients with longer follow-up. Despite the profile frame raise due to the evolution of Edwards® balloon-expandable THVs, PCI or coronarography feasibility were not compromised in our population.

Long-Term Results After Aortic Valve Replacement with Last-Generation Stentless Prostheses.

INTRODUCTION: The purpose of this study was to evaluate the long-term clinical and hemodynamic results in patients affected by severe aortic valve disease after aortic valve replacement with third-generation stentless aortic prostheses (3F® stentless equine pericardial [Medtronic plc, Minneapolis Minnesota] and Pericarbon Freedom™ stentless bovine pericardial [LivaNova plc, London, United Kingdom]) and to analyze the benefits and the drawbacks associated to their use. MATERIALS AND METHODS: Between June, 2003 and Sept, 2015 a cohort of 548 consecutive patients affected by aortic valve disease received an aortic valve replacement using a last-generation stentless pericardial aortic prosthesis at our unit. Respectively, 322 patients received a Pericarbon Freedom™ and 226 received a 3F® aortic valve. Size ranged between 19 and 29, with prevalence of 23 and 25 devices. Mean age at operation was 71± 11 years, 57% of patients were males, the mean logistic EuroScore was 8.9 ± 7.2 and 44.2% received concomitant procedures. The mean extracorporeal circulation (ECC) time was 119.2 ± 40.6. The mean cross clamp time was 90.5' ± 21.4'. In 30 patients, the aortic prosthesis was included in a Dacron tube straight graft for a Bentall operation. RESULTS: Early/in-hospital mortality was 2.55% (14 cases) for the entire cohort. In patients receiving isolated aortic valve replacement (AVR), it was 0.91% (5 cases). Follow up ranged between six months and 12 years (median follow-up time: 6.77 years). During follow up, 137 patients died of all causes (25%), of whom 32 patients died of cardiac causes (5.8%). Cardiac survival probability was 91% at 12 years. All surviving patients were in NYHA class I at last follow up. Actuarial freedom from structural valve deterioration was 86% at 12 years. Freedom from endocarditis was 95% at 12 years. Freedom from a valve-related reoperation at 12 years follow up was 95%. Mean residual transprosthetic gradient at 12 years was 10.3 ± 4.8MmHg. CONCLUSIONS: Last-generation stentless pericardial valves offer excellent hemodynamics and adequate durability and freedom from structural deterioration at 12 years follow up. The implantation technique of a stentless valve is a little more demanding when compared to a stented valve, but it can be easily reproduced after minimal training. Incidence of endocarditis and thromboembolic events is low and comparable to stented pericardial valves. Young and active patients, and patients with large BSA where a patient-prosthesis mismatch may be anticipated are, in our opinion, ideal candidates to receive these kinds of valves.

Outcomes after surgical ventricular restoration for ischemic cardiomyopathy.

OBJECTIVE: The study objective was to evaluate the short- and long-term outcomes of patients with ischemic cardiomyopathy after surgical ventricular restoration and to identify risk factors related to poor results. METHODS: Between August 2002 and April 2016, 62 patients affected by ischemic cardiomyopathy underwent surgical left ventricular restoration at our unit. Patients' mean age at operation was 63 years (39-79 years). Mean ejection fraction was 29.6%. The Surgical Treatment for Ischemic Heart Failure trial criteria have been used as indications for surgery. Fifty-seven patients (91%) received surgical myocardial revascularization. Mitral valve repair was performed in 39 patients (63%). The surgical technique consisted of the classic Dor operation or a different approach reducing the equatorial diameter of the left ventricle and avoiding the use of a patch. The data were analyzed retrospectively for perioperative results and short- and long-term clinical outcomes. RESULTS: One patient died of noncardiac causes within 30 days (1.6%). All-cause death occurred in 36 patients (58%) during follow-up (0.6-14.7 years; median follow-up time, 7.02 years), of whom 15 died of cardiac causes. Age, need for preoperative intra-aortic balloon pump, reduction less than 35% of postoperative left ventricular end-diastolic and end-systolic volumes, type of surgical technique, and ejection fraction less than 25% were identified as risk factors for late cardiac mortality. Perioperative levosimendan administration and presence of preoperative moderate to severe mitral regurgitation influenced early and intermediate-term outcomes, but no statistical relevance on long-term results was demonstrated. CONCLUSIONS: Patients with ischemic dilative cardiomyopathy have favorable short- and long-term outcomes after ventricular restoration. Age, preoperative ejection fraction less than 25%, inadequate left ventricular surgical reverse remodeling, and type of surgical technique negatively affect long-term survival.

Surgical Treatment of Ischemic Dilative Cardiomyopathy by Ventricular Restoration.

Patients with symptomatic post-ischemic dilative myocardiopathy of the left ventricle require, in selected cases, an operation to reshape and reduce the volume of the left ventricular chamber, in addition to surgical myocardial revascularization and mitral valve repair, with the aim of prolonging survival, improving the quality of life and minimizing the need for re-hospitalizations related to recurrent heart failure. This procedure is called surgical ventricular restoration (SVR), and is a useful tool for the treatment of heart failure patients as an alternative to heart transplant. This article provides an overview of surgical ventricular restoration for the treatment of dilative ischemic myocardiopathy. It illustrates several surgical options, describes the operative details, and discusses the correct indications for the procedure. Finally, an interesting protocol for one-step cell therapy during SVR is proposed, as an innovative treatment for heart failure patients.

Outcome at 26 Years After Repair of Fallot's Tetralogy With Absent Left Pulmonary Artery.

We report long-term outcome after two-stage, "one lung repair" in a four-year-old boy with tetralogy of Fallot and congenital absence of the left pulmonary artery. The operation was carried out two years after a palliative aortopulmonary central shunt and was uneventful. Twenty-six years later, the patient is in excellent clinical condition, with normal peripheral oxygen saturation. A recent radionuclide lung scan and cardiac magnetic resonance imaging show the pulmonary flow entirely directed into the right lung. In selected cases, the long-term prognosis of patients with tetralogy of Fallot and true absence of left pulmonary artery after "one lung repair" may be excellent.

Cell therapy and left ventricular restoration for ischemic cardiomyopathy: long-term results of a perspective, randomized study.

BACKGROUND: Aim of this study is to verify the potential advantages and benefits of bone-marrow derived autologous stem cells implantation associated to surgical left ventricular restoration (SVR), to report a new modality of cell delivery to myocardium, and to identify possible side effects of this procedure. METHODS: Between March 2007 and March 2013, 30 patients affected by ischemic dilative cardiomyopathy who received a SVR operation were enrolled in the study. The population was divided in two groups:16 patients were randomly assigned to receive stem cells therapy in addition to SVR (groupA), 14 patients received a placebo (group B). The two groups were homogeneous in respect of age, gender, preoperative NYHA class, mitral incompetence and left ventricular sizes and volumes. The patients were evaluated by echo and pet-scan before surgery and at 6 months follow-up, and by echo at subsequent follow-up. RESULTS: Overall 30 days-in hospital mortality was 0 for the entire cohort. At last follow-up ejection fraction increased from 25.3% before surgery to 36.3% in group A, and from 31.8% to 45.6% in group B. Reduction of LVEDD was 6% in group A, 9% in group B. ESLVV and EDLVD decreased more significantly in patients receiving stem cells (55% vs. 35%). Late cardiac mortality at 9 years follow-up was similar in the two groups of patients. No early or late adverse reaction nor cases of infections were observed. CONCLUSIONS: Patients affected by ischemic cardiomyopathy have a favourable outcome after SVR. A higher reduction of LVEDV and LVESV assessed by CT-Scan evaluation in patients receiving cell therapy, when compared to control group, encourages the evolution and refinement of myocardial regenerative therapy added to SVR.

Outcomes of a New-Generation Stentless Aortic Valve: A Single-Center Experience with 251 Consecutive Implants.

BACKGROUND: The study aim was to investigate the hemodynamic behavior over time and ease of implant and durability of the Sorin Pericarbon Freedom (SPF)® stentless pericardial aortic xenograft. METHODS: Between March 2003 and April 2010, a total of 251 consecutive, non-selected patients (mean age 70.1 years; range: 17-89 years; 17.1% aged >80 years) received a SPF bioprosthesis as an aortic valve substitute at the authors' institution. All implantations were performed by a single surgeon using a classical, double-line, subcoronary implant technique. Of these patients. 108 (43%) underwent a concomitant procedure. The mean logistic EuroSCORE was 8.3. Patients were followed for complications and hemodynamic evaluation. Echocardiographic controls and clinical data were obtained at discharge, and at six months' and eight years' follow up. RESULTS: The in-hospital/30-day mortality was 1.2% for the entire group, but 0% for patients with isolated valve replacement. A total of 27 deaths had occurred at the time of the last follow up (22 were due to non-cardiac causes). At follow up (mean 3.7 years; range: 0-7.8 years), 91.1% of survivors were in NYHA classes I or II. Freedom from reoperation and from structural valve deterioration was 96.0% and 96.8%, respectively, at 7.8 years. The mean pressure gradient of the series (measured using echocardiography) was 10.3 ± 4.5 mmHg at discharge, and 8.3 ± 4.5mmHg at the time of the last follow up. The mean effective orifice area was 1.85 ± 0.70 cm2 for the entire series, and there was an absence of prosthesis-patient mismatch in 90% of patients. CONCLUSIONS: The study results confirmed the favourable hemodynamic behavior, low risk of implantation and acceptable durability of the pericardial stentless SPF aortic prosthesis. The data also endorsed use of the SPF as an aortic valve substitute, even in a young and active population, and particularly in the presence of a small aortic annulus. The accuracy of implantation remains a crucial factor for durability and subsequent satisfactory hemodynamic performance. A longer follow up would provide further information with regards to complications and durability of the SPF prosthesis.

Benefits and medium-term outcome of the Sorin Pericarbon Freedom stentless aortic prosthesis in cases of acute bacterial endocarditis.

OBJECTIVES: The aim of this study is to evaluate the ease of use and the advantages of Sorin Pericarbon Freedom (SPF) stentless valve in cases of acute bacterial endocarditis and to check the intermediate-term results after the implant of SPF with respect to resistance to infection, valve deterioration and durability. METHODS: Between June 2003 and February 2015, 26 patients with active aortic valve bacterial endocarditis underwent aortic valve replacement with SPF pericardial stentless aortic prosthesis. The mean age was 57 ± 18 years; 73% of the patients were in preoperative NYHA class III and VI. Mean Logistic EuroSCORE was 14.2 ± 12.7. Endocarditis occurred in 18 patients with native valves, and in 9 patients with prosthetic valves (4 mechanical aortic valve prostheses; 5 aortic bioprostheses). Aortic root abscesses were observed in 16 cases (61.5%). Surgery was emergent in 3 cases (11.5%). Redo surgery was performed in 9 cases (35%). Cumulative follow-up was 126.8 patient-years (mean 4.9 ± 3.3 years). RESULTS: Operative hospital mortality was 0% for all patients. Residual mean prosthetic gradient at discharge was 9.4 ± 3.6 mmHg. Neither residual aortic incompetence nor residual abscess cavity was observed at discharge. Mean ejection fraction at discharge was 54 ± 8% (Min; Max: 35%; 65%). A total of 4 patients died at follow-up, all for non-cardiac causes. One patient was lost to follow-up. Two patients (8%) underwent non-valve-related reoperation with 0% mortality. Residual mean gradient at follow-up was 7.2 ± 2.1 mmHg. Three patients (17%) presented with mild/moderate aortic incompetence and 89% of patients were in NYHA Class I-II at follow-up. At 9 years, actuarial freedom from valve-related reoperation and from structural valve deterioration was 100%. CONCLUSIONS: The SPF aortic prosthesis is a true pericardial stentless prosthesis suitable for the treatment of acute bacterial endocarditis. Intermediate-time results in terms of freedom from reoperation, structural valve deterioration and resistance to infections are satisfactory. Haemodynamic performances are excellent since a complete exclusion of aortic root abscesses is achieved without any reduction of the aortic annular diameter, usually due to marsupialization or patch closure of the infected cavities.

Point-of-care-based protocol with first-line therapy with coagulation factor concentrates is associated with decrease allogenic blood transfusion and costs in cardiovascular surgery: an Italian single-center experience.

BACKGROUND: Transfusion in patients having cardiac surgery has been associated with increased morbidity, mortality, and costs. This analysis assessed the impact of a rotational thromboelastometry (ROTEM®)- and functional platelet assessment (Multiplate®)-based protocol for bleeding management on perioperative outcomes and costs in patients undergoing cardiac surgery. METHODS: This retrospective analysis of the records of all patients who underwent cardiac surgery at the Hesperia Hospital, Modena, Italy, from December 2012 to December 2013 compared outcomes and costs of bleeding management for the two 6-month periods before/after introduction of the ROTEM- and Multiplate-based protocol. Descriptive and correlation analysis were performed as appropriate. Propensity score matching and its correlation analysis were performed. RESULTS: Data from 768 consecutive patients (mean age ~69 years, ~66% male) were included; 50.7% and 49.3% of patients had surgery before and after protocol introduction, respectively. Significantly fewer patients required transfusions of packed red blood cells after the protocol introduction over the 24 hours postsurgery (100 vs. 197 patients; P<0.001) and during ICU stay (134 vs. 221 patients; P<0.001). A significantly greater proportion of patients treated after protocol introduction received prothrombin complex concentrate (31 vs. 16; P<0.05) and fibrinogen concentrate (36 vs. 13; P<0.001). A significantly greater proportion of patients treated after protocol introduction had an ICU stay duration <48 hours (81.5% vs. 71.5%; P<0.001). ROTEM-based bleeding management was associated with a saving of €128,676.23 for the 379 patients undergoing surgery post-protocol introduction (€339.52 per patient). CONCLUSIONS: ROTEM-guided bleeding management in patients undergoing cardiac surgery was cost-effective and associated with an increase of administration of coagulation factor concentrates and a decrease of ICU length of stay.

ECMO for pulmonary rescue in an adult with amiodarone-induced toxicity.

Amiodarone is a highly effective antiarrhythmic agent. Unfortunately amiodarone-induced pulmonary toxicity is described for medium-long term therapy. We describe a case of a 65-year-old man admitted to our department for breathlessness and with a history of recurrent episodes of atrial fibrillation for which he had been receiving amiodarone (200 mg/day) since 2008. Despite diuretic therapy, along with aspirin, statins and antibiotics the patient continued to complain of severe dyspnea and had a moderate fever. Thus, diagnostic hypotheses different from acute cardiac failure were considered, in particular non-cardiogenic causes of pulmonary infiltrates. Following suspicion of amiodarone-induced pulmonary toxicity, the drug was discontinued and corticosteroid therapy was initiated. Due to the deterioration of the clinical picture, we proceeded to intubation. After few hours from intubation we were forced to institute a veno-venous extracorporeal membrane oxygenation due to the worsening of pulmonary function. The patient's clinical condition improved which allowed us to remove the ECMO after 15 days of treatment. Indications for use of ECMO have expanded considerably. To our knowledge this is the first successful, reported article of a veno-venous ECMO used to treat amiodarone-induced toxicity in an adult. In patients with severe but potentially reversible pulmonary toxicity caused by amiodarone, extracorporeal life support can maintain pulmonary function and vital organ perfusion at the expense of low morbidity, while allowing time for drug clearance.

Consideraciones sobre la hipnosedación en el postoperatorio de cirugía cardíaca pediátrica / Considerations on hypnosedation in the postoperative period of pediatric heart surgery

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Adrenomedullin blood concentrations in infants subjected to cardiopulmonary bypass: correlation with monitoring parameters and prediction of poor neurological outcome.

BACKGROUND: Brain injury is a major adverse event after cardiac surgery, especially when extracorporeal circuits are used. We evaluated whether cardiopulmonary bypass (CPB) affects cerebrovascular resistance and plasma concentrations of adrenomedullin (AM), a vasoactive peptide regulating cerebral blood flow. METHODS: We evaluated 50 infants (age <1 year) with congenital heart defects, matched according to a 2-year follow-up; 40 infants had no overt neurological injury, and 10 had brain damage. Blood samples were taken before surgery, during surgery before CPB, at the end of CPB, at the end of surgery, and at 12 h after surgery. Neurological outcome was evaluated before surgery, on postoperative day 7, and 2 years after surgery. We measured AM concentrations and used Doppler velocimetry to measure middle cerebral artery (MCA) pulsatility index (PI). RESULTS: The highest MCA PI values and lowest AM concentrations occurred at the end of CPB and of the surgical procedure. Infants who developed abnormal neurologic sequelae had significantly (P <0.001 for both) higher MCA PI values and lower AM concentrations than patients with normal neurologic outcome at the end of CPB and after surgery. As single markers for predicting neurological abnormalities, AM (cutoff: 17.4 ng/L) achieved a sensitivity of 100% and a specificity of 73.0% and MCA PI (cutoff value: 1.8) a sensitivity of 100% and a specificity of 56.8%. CONCLUSIONS: AM concentrations and MCA PI patterns change during CPB, mainly in infants with brain damage, and may be useful for early identification of infants at risk for brain damage.

S100B blood levels correlate with rewarming time and cerebral Doppler in pediatric open heart surgery.

BACKGROUND: Brain hyperthermia, accompanying the rewarming phase of cardiopulmonary bypass (CPB), has been involved in the genesis of postoperative brain damage. Blood S100B levels are emerging as a marker of brain distress, and could offer a reliable monitoring tool at different times during and after open heart surgery. METHODS: Thirty-two patients undergoing repair of congenital heart disease with CPB and deep hypothermic circulatory arrest (DHCA) were monitored by S100B blood levels and middle cerebral artery Doppler velocimetry pulsatility index (MCA PI) before, during, and after surgical procedure at five predetermined time-points. RESULTS: Both S100B and MCA PI significantly increased, MCA PI values exhibiting a peak at the end of surgery time-point (p > 0.05), while S100B blood levels were increased at the end of CPB (p < 0.05). Multivariate analysis, with S100B levels measured at the end of CPB as dependent variable, showed a positive significant correlation with MCA PI (p = 0.04), with the CPB and the rewarming duration (p = 0.03 and p = 0.009, respectively). CONCLUSIONS: The present results show a significant correlation between a biochemical marker of brain damage and an index of increased cerebrovascular resistance, with higher levels during the rewarming CPB phase in pediatric open heart surgery.